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Regulatory Affairs Manager – Generics
TRIGA Consulting GmbH & Co. KGRegulatory Affairs Manager ensuring compliance in licensing processes for a leading pharmaceutical company. Handling documentation, managing life-cycle processes, and liaising with authorities in a hybrid work setting.
About the role
Key responsibilities & impact- Independent management of marketing authorization procedures
- Preparation of regulatory submission documentation in eCTD format and submission to authorities
- Life-cycle management (renewals, variations)
- Direct contact with regulatory authorities and point of contact for internal and external RA queries
- Maintenance and optimization of the regulatory information database
- Drafting and review of product information texts
Requirements
What you’ll need- A completed degree (e.g., pharmaceutical or natural sciences)
- Professional experience in Regulatory Affairs
- Excellent German and English language skills
- Strong analytical thinking, quick comprehension, and good organizational skills
- Team player with strong communication skills
Benefits
Comp & perks- Flexible work arrangements (including home office)
- 30 days annual leave + 3 bridge days
- A friendly team
- Attractive salary & comprehensive social benefits (including pension and health care provisions…)
- Excellent training and development opportunities
ATS Keywords
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Hard Skills & Tools
regulatory submission documentationeCTD formatlife-cycle managementproduct information texts
Soft Skills
analytical thinkingorganizational skillscommunication skillsteam player
Certifications
degree in pharmaceutical sciencesdegree in natural sciences